Among problems that physicians have encountered during diagnostic or surgical procedures, using both “open” techniques, and minimally invasive (laparoscopic) surgical techniques, are numerous post procedural complications. These complications can consist of, but are not limited to, post operative pain, infections, tissue adhesions, and tumor formation. Numerous products, such as medications and associated delivery systems, addressing these issues exist on the market to improve the surgical or invasive experience and patient outcomes. Among these products are suction and irrigation wands that are used for flushing tissue sites with sterile water or saline and removing blood. There are medications, which are spread over exposed organs, to coat or provide a barrier between tissue and organs for prevention of adhesions. These materials may be in gel form, sheet form, spray (liquid) form, or aerosol form to coat organs or tissues, or to provide thin layer deposition to the organs in the operative site. Some of these materials may be used in both open and minimally invasive surgical techniques.
The problems with these materials, and their application as related to laparoscopy, are their inability to be used easily and effectively in a minimally invasive laparoscopic environment. Among the difficulties associated with spraying of liquids, is the pooling and lack of containment of the fluids used with irrigation and aspiration wands. It is also difficult to cover large areas (greater than several square centimeters), and do so without using much more medicament than is necessary. This contributes to the cost of excessive medication, and adding to the cost and time of the surgery.
Materials used in sheet form are not practical to apply to the organs when using laparoscopic minimally invasive techniques, due to the difficulty in getting the material through standard trocars, and then spreading the material out over the affected area, and keeping it in place once positioned. The liquid spray technique has many of the same problems as the irrigation approach. These devices normally force a liquid through a cannula like device under pressure. The introduction of additional fluid into the body cavity can cause increases in pressure and do not include a means for pressure relief. Without a means for directing the spray, it is difficult to control where the medication is deposited, and in what amount. Also, the precise disposition of the medication as to amount and location is difficult to control.
Compound materials are sometimes mixed prior to being aerosolized by a hand held syringe device, and then by applying an air stream to the mixed medication as it is being dispensed, to create an aerosolized stream that is used to “paint” the organs. This method also ignores the problem of the creation of additional pressure in the organ with no relief mechanism. Creating an aerosol “cloud” contends with the problem of how to effectively coat all the surfaces required, but also introduces the problem of increasing abdominal pressures uncontrollably inside an insufflated body cavity or organ, such as the peritoneum.
All of the above methodologies, while focused on applying substances in different physical forms for the purpose of treating or coating tissues and/or organs, have not been optimized for use in the laparoscopic, minimally invasive environment. The term “substance”, as used in this specification, includes, without limitation, a liquid, powder or gas, or any combination thereof.